The invention relates generally to a therapeutic or prophylactic vernix composition and method.
Skin is one of the largest organs in the body and covers substantially the entire body surface. Skin is composed of two main layers: the surface epithelium or epidermis which includes the uppermost stratum corneum, and the subjacent connective tissue layer or dermis. The skin has a number of functions such as protecting an organism from injury and dessication, receiving environmental stimuli, excreting various substances, regulating body temperature and helping to maintain water balance. Because of its quantitative and qualitative importance, substantially intact and healthy skin is crucial not only for the well being of an organism but for its very survival.
The health and integrity of skin may be compromised by wounds, abrasions, ulcers, burns, infections, irritations, premature birth and other conditions for which normal skin production and repair processes may be inadequate. For example, acute conditions such as patients who are burned over a large surface area often require immediate skin replacement. Less life-threatening but chronic skin problems such as decubitus ulcers or irritations from diaper rash may progress to more severe conditions if left untreated or if they occur in a neonate or a geriatric patient. Skin treatments encompass a variety of methods and products. These may range from symptomatic treatments such as the use of topical anti-inflammatory compounds to the use of replacement skin. For various physiological, medical, and other reasons, however, none of these treatments meet the desired goal of utilizing the body""s own healing and repair system to promote and regulate its own skin growth and maturation.
Exposure of the skin to water over a prolonged time period produces deleterious effects on the integrity and condition of the skin, such as maceration and damage to the barrier function of skin. For example, long term water exposure is a known cause of dermatitis. Dermatitis, defined as an inflammation of the skin, is a major problem in professions in which a portion of the skin is subject to prolonged water exposure (the so-called xe2x80x9cwet professionsxe2x80x9d). Soldiers serving in tropical climates are also known to suffer from painful swollen feet (xe2x80x9ctropical immersion footxe2x80x9d) due to long term water exposure. Such situations comprise a large part of occupational medicine and have a significant economic impact. Thus, there is a need for treatment and prevention of these deleterious effects on the skin.
Vernix caseosa (vernix) is a naturally occurring skin protectant. Vernix is a lipid rich substance composed of sebum, epidermal lipids, and desquamated epithelial cells that progressively covers the skin of the developing fetus, completely surrounded by amniotic fluid, during the last trimester of pregnancy.
Vernix consists of hydrated cells dispersed in a lipid matrix. This lipid matrix undergoes a transition to a more fluid form at physiological temperatures and with the application of shear forces, such as those encountered with movement. Vernix is a covering for the skin of the fetus that resembles the stratum corneum except that it lacks multiple rigid desmosomal connections. Consequently, vernix exhibits a viscous fluid character, making controlled management and/or application to a surface difficult.
A need thus exists for a formulation that can be applied to a biological surface such as skin for treatment and prevention of conditions related to skin surface properties.
The invention is directed to a method to enhance hydrophobicity of a biological surface by applying a composition of vernix and a dispersing agent to the surface. The composition is applied to the surface, e.g., skin, in an amount effective to enhance hydrophobicity. Vernix, natural and/or synthetic, may be formulated as a cream, a lotion, a gel, an ointment, etc.
The invention is also directed to a method to regulate skin hydration by applying a composition of vernix and a dispersing agent to the skin in an amount effective to regulate hydration. The method may be used on developing skin, such as wounded skin or skin on a preterm newborn.
The invention is also directed to a method to enhance skin repair by regulating the water gradient of skin with a composition of vernix and a dispersing agent in an amount effective to regulate the water gradient. The composition may be used to repair trauma from a physical or chemical source.
The invention is also directed to a method to enhance hydrophobicity of a biological surface by applying a vernix film to the surface in an amount effective to achieve a surface free energy of at least about 20 dyne/cm. In one embodiment, the vernix is applied in an amount to achieve a surface free energy of about 40 dyne/cm.